Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer
Study Details
Study Description
Brief Summary
The aim of this study is to evaluate the increase of radiation dose administered in patients diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using IMRT (concomitant boost technique).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The hypothesis that arises is an improvement in the proportion of pathological complete responses, resulting therapeutic gain, as a result of a higher dose of radiation delivered to the tumor volume without incurring a higher gastrointestinal toxicity to the patient or surgical complications later, thanks to the use of intensity modulated radiotherapy (concomitant boost technique) that allows us to significantly reduce the administered dose organs at risk.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment with IMRT Dose Escalation Dose Escalation Intensity Modulated Radiotherapy treatment |
Radiation: Dose Escalation Intensity Modulated Radiotherapy treatment
Radiotherapy:
IMRT treatment (concomitant boost technique) 25 fractions fraction 2,15Gy by administering a total dose of tumor and lymph nodes 53,75Gy on more margin. Simultaneously we will proceed to the irradiation of pelvic lymph node chains according to protocol, a division of 1,8Gy per session until a total dose of 45 Gy.
Chemotherapy:
According to routine clinical practice of the participating centers.
|
| Active Comparator: Treatment with 3DCRT 3DCRT treatment (sequential boost) |
Radiation: 3DCRT treatment (sequential boost)
Radiotherapy:
3DCRT treatment (sequential boost) 25 fractions fraction 1,8Gy by administering a total dose of 45 Gy on tumor and lymph nodes and lymph node chains more pelvic margin determined according to protocol.
3 fractions fraction 1,8Gy by sequentially administering an additional dose of tumor and lymph nodes 5,4Gy on more margin.
Chemotherapy:
According to routine clinical practice of the participating centers.
|
Outcome Measures
Primary Outcome Measures
- Pathologic complete response [Through study completion, an average of 2 years]
Pathologic evaluation of the surgical specimen as assessed by Mandard Tumor regression scoring
- Gastrointestinal toxicity [Two years]
Gastrointestinal adverse events as assessed by CTCAE v4.0
Secondary Outcome Measures
- Tumor regression grade [Through study completion, an average of two years]
Pathologic evaluation of the surgical specimen
- Disease free survival [Three years]
- Overall survival [Five years]
- Acute Toxicity [Two years]
Acute Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis proctitis, urinary frequency/urgency as per common toxicity criteria V4.03
- Quality of Life during the treatment [Three years after the study completion]
Assessed by EORTC QLQC30-CR29 questionnaries
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pathologically proven diagnosis of adenocarcinoma of the rectum
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Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum
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Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least <11cm from the anal verge
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Adequate liver/renal and haematological function.
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Eastern Cooperative Oncology Group (ECOG) performance 0-2
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Age ≥ 18 years
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Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
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Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
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Platelets ≥ 100,000 cells/mm3
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Haemoglobin ≥ 8.0 g/dl
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Serum creatinine within normal institutional limits
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Bilirubin within normal institutional limits
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AST and ALT < 2.5 x the IULN
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Patient must sign study specific informed consent prior to study entry
Exclusion Criteria:
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Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable.
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Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
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Any evidence of distant metastases (M1)
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A synchronous primary colon carcinoma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital General de Elche | Elche | Alicante | Spain | |
| 2 | Consorcio Hospitalario Provincial de Castellón | Castellón De La Plana | Castellón | Spain | |
| 3 | Hospital Universitario Santiago de Compostela | Santiago de Compostela | La Coruña | Spain | |
| 4 | Hospital Universitario Rey Juan Carlos | Mostoles | Madrid | Spain | |
| 5 | Hospital General Universitario de Ciudad Real | Ciudad Real | Spain | ||
| 6 | Hospital Universitario de Fuenlabrada | Fuenlabrada | Spain | ||
| 7 | Hospital Universitario Ramón y Cajal | Madrid | Spain | 28034 | |
| 8 | Hospital Universitario La Paz | Madrid | Spain | ||
| 9 | Hospital Clínico Universitario de Valencia | Valencia | Spain |
Sponsors and Collaborators
- Grupo de Investigación Clínica en Oncología Radioterapia
Investigators
- Principal Investigator: Fernando López Campos, Investigator, Hospital Universitario Ramón y Cajal
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RTRC--001