Clinical trial · Interventional
Optimization of Preoperative Treatment in Locally Advanced Rectal Cancer
Phase III Study of Short-term Radiotherapy Plus Neoadjuvant Chemotherapy Versus Preoperative Long-term Chemoradiotherapy in Locally Advanced Rectal Cancer
NCT02533271CI-TRIAL-00052744STELLARunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to compare effectiveness of short-term radiotherapy with neoadjuvant chemotherapy(TNT group) with preoperative long-term chemoradiotherapy(CRT group) in locally advanced rectal cancer. The hypothesis is 3-year disease-free survival in TNT group was non-inferior to that in CRT group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Rectum | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Long-term chemoradiotherapy | Radiation | — | UNRESOLVED |
| Short-course radiotherapy with neoadjuvant chemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TNT group
- description
- The intervention of TNT group is Short-course radiotherapy with neoadjuvant chemotherapy, which consists of a short-course radiotherapy (SCRT, 5 Gy x 5 alone), then after 7-10 days of radiotherapy completed, patients will receive neoadjuvant chemotherapy, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are prescribed preoperatively, then followed by a total mesorectal excision(TME) and postoperative adjuvant chemotherapy. If patients are eligible for postoperative chemotherapy this should consist of at least 2 cycles, which are the same as neoadjuvant chemotherapy.
- interventionNames
- Radiation: Short-course radiotherapy with neoadjuvant chemotherapy
- type
- OTHER
- label
- CRT group
- description
- The intervention of CRT group is long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively, followed by a total mesorectal excision(TME) and then postoperative adjuvant chemotherapy. The radiotherapy is given in combination with capecitabine in a dose of 825 mg/m2 twice daily on days when radiotherapy, excluding weekends. If patients are eligible for postoperative chemotherapy this should consist of at least 6 cycles of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once every 3 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven rectal adenocarcinoma; * Distance between tumour and anal verge≤ 10cm; * Locally advanced tumour;(AJCC Cancer Staging:T3, T4 or N+) * Cancer Staging must be based on pelvic MRI; * Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1; * Written informed consent; * Mentally and physically fit for chemotherapy; * Adequate blood counts: White blood cell count ≥3.5 x 109/L Haemoglobin levels ≥100g/L Platelet count ≥100 x 109/L Creatinine levels ≤1.0× upper normal limit（UNL） Urea nitrogen levels ≤1.0× upper normal limit（UNL） Alanine aminotransferase(ALT) ≤1.5× upper normal limit（UNL） Aspartate aminotransferase(AST) ≤1.5× upper normal limit（UNL） Alkaline phosphatase(ALP) ≤1.5× upper normal limit（UNL） Total bilirubin(TBIL) ≤1.5× upper normal limit（UNL） * No excision of tumor, chemotherapy or other anti-tumor treatment after the diagnosis. Exclusion Criteria: * Distant metastases; * Recurrent rectal cancer; * Active Crohn's disease or ulcerative colitis; * Concomitant malignancies;(except basocellular carcinoma or in-situ cervical carcinoma) * Allergic to Fluorouracil or Platinum drugs; * Contraindications to MRI for any reason; * Concurrent uncontrolled medical condition; * Pregnancy or breast feeding; * Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract; * Symptoms or history of peripheral neuropathy
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Yuan Tang, Hai-Tao Zhou, Tong-Zhen Xu et al. · J Clin Oncol · Sep 1, 2026 · PMID 42507974 pubmed
- DERIVEDTang Y, Zhou HT, Xu TZ, Li N, Jiang LM, Jiang J, Lu NN, Li S, Chen SL, Ma HY, Cai Y, Li YH, Zhu Y, He MY, Wang X, Liu K, Zhang HY, Wang J, Zhao T, Li GF, Yang JL, Zhang K, Wang WL, Xiao WW, Chi Y, Yang L, Zhou AP, Zou SM, Fang H, Wang SL, Zhang HZ, Wang XS, Wei LC, Liu SX, Gao YH, Li YX, Hu C, Jin J. Five-Year Outcomes of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy for Locally Advanced Rectal Cancer: Updated Results of the STELLAR Trial. J Clin Oncol. 2026 Sep;44(25):2371-2378. doi: 10.1200/JCO-25-02387. Epub 2026 Jul 27. PMID 42507974
- DERIVEDWang N, Xu T, Li H, Shuai J, Ma H, Fang H, Song Y, Chen B, Lu N, Jing H, Liu X, Qi S, Zhang W, Liu Y, Li Y, Wang S, Dou L, Jin J, Tang Y. Diabetes and Performance Status Predict Severe, Persistent Radiation Proctitis: Long-Term Endoscopic Findings From STELLAR Trial. Int J Radiat Oncol Biol Phys. 2026 May 15:S0360-3016(26)00722-4. doi: 10.1016/j.ijrobp.2026.05.004. Online ahead of print.