Clinical trial · Interventional
NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer
NEOadjuvant Chemotherapy Only Compared With Standard Treatment for Locally Advanced Rectal Cancer: a Randomized Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main clinical hypothesis is that compared to radio-chemotherapy for low and mid rectal tumors or surgery for high rectal tumors neoadjuvant chemotherapy reduces the rate of distant relapse without increasing the rate of local relapse. The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery Furthermore, early surgical and medical complications, the functional outcome, toxicity and quality of life (QoL) may be improved if radiotherapy can be avoided. Exploratory analyses are planned in order to find potential predictive markers for selecting patients to either radio-chemotherapy/surgery or neoadjuvant combination chemotherapy/surgery.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Intestinal Disease | — | UNRESOLVED | — |
| Intestinal Neoplasms | Intestinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| CAPOX (oxaliplatin/capecitabine) | Drug | CAPOX Regimen | ALIAS |
| FOLFOX regimen (oxaliplatin/leucovorin/5FU) | Drug | FOLFOX Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A, capecitabine
- description
- Radiochemotherapy with 50.4 Gy in 28 fractions concomitantly with chemotherapy
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- B, FOLFOX or CAPOX
- description
- Neoadjuvant chemotherapy with CAPOX (oxaliplatin/capecitabine) or FOLFOX regimen (oxaliplatin/leucovorin/5FU), according to institutional practice
- interventionNames
- Drug: FOLFOX regimen (oxaliplatin/leucovorin/5FU)
- Drug: CAPOX (oxaliplatin/capecitabine)
Primary outcomes (1)
- measure
- Disease free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the rectum with the lower boarder within 15 cm from the anal verge * Locally advanced tumor based on imaging * T3 tumors within 10 cm from the anal verge fulfilling the criteria for preoperative radio-chemotherapy according to Danish Colorectal Cancer Group (DCCG) guidelines * T3c or T4 tumors 10-15 cm from the anal verge * Deemed resectable at the multidisciplinary team (MDT) conference * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Age at least 18 years * Adequate bone marrow, liver and renal function allowing systemic chemotherapy * Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. * Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value * Calculated or measured renal glomerular filtration rate at least 30 mL/min * Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable * Written and orally informed consent Exclusion Criteria: * Distant metastasis * Invasive ingrowth into other organs * Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy * Previous radiotherapy to the pelvis * Previous treatment with 5FU or oxaliplatin * Surgery within two weeks * Neuropathy NCI grade \> 1 * Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri * Pregnant (positive pregnancy test) or breast feeding women
References
Publications (0)
Data not yet available