20 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD)Primary· 5-6 weeks during study treatment
The MTD is defined as the maximum dose level in the doses of temozolomide tested with capecitabine and radiation in which the incidence proportion of DLT exceeds 30%.
Group
Value
95% CI
Dose Level 1
0
Dose Level 2
0
Dose Level 3/Recommended Dose
0
Recommended Dose (RD)Primary· 5-6 weeks after CRT
RD will be defined as one level below the MTD.
Group
Value
95% CI
Dose Level 1
0
Dose Level 2
0
Dose Level 3/Recommended Dose
75
Pathological Complete ResponseSecondary· at the time of surgery (6-8 weeks after study treatment)
Pathologic responses and stages were classified according to Dworak's classification and the 7th edition of the American Joint Committee on Cancer staging system, respectively.
The pathologic complete response (pCR) was defined as the total regression of the primary tumor regardless of regional lymph nodal status (ypT0), with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells.
Group
Value
95% CI
Unmethylated MGMT
1
Hypermethylated MGMT
6
Toxicity(Adeverse Event)Secondary· 5-6 weeks during study treatment
Toxicity will be monitored and recorded every week during study treatment (5 or 6 weeks) as following according to the NCI-CTCAE version 4.0
1. An interval history and physical examination with particular attention to drug-induced side effects along with documentation of the patient's weight and performance status will be performed on each visit.
2. CBC with differential count, blood chemistry including calcium, phosphorus, glucose, BUN, creatinine, total protein, albumin, AST, ALT, alkaline phosphatase, total bilirubin, and electrolyte will be performed before next planned treatment.
3. All
Any grade 1 adverse event
Group
Value
95% CI
Dose Level 1
6
Dose Level 2
8
Dose Level 3/Recommended Dose
60
Any grade 2 adverse event
Group
Value
95% CI
Dose Level 1
2
Dose Level 2
2
Dose Level 3/Recommended Dose
17
Any grade 3 adverse event
Group
Value
95% CI
Dose Level 1
1
Dose Level 2
0
Dose Level 3/Recommended Dose
3
Any grade 4 adverse event
Group
Value
95% CI
Dose Level 1
0
Dose Level 2
0
Dose Level 3/Recommended Dose
0
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The investigators planned a phase I study of preoperative CRT with capecitabine plus temozolomide inpatients with locally advanced resectable rectal cancer: 1) the role of temozolomide as a radiosensitizer has been well established, 2) hypermethylation (or low expression) of MGMT promoter is associated with colorectal carcinogenesis, can be found in 20\~40% of colorectal cancer patients, and this proportion could be adequate for validation as its role of predictive biomarker, and 3) temozolomide can be additive or synergistic because radiotherapy is now essential in the treatment of rectal cancer.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT06448286 — PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glio
· Phase 3
· not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S
· Phase 2
· not yet recruiting
NCT07452458 — Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, ID
· Phase 3
· not yet recruiting
NCT06639607 — PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/Hi
· Phase 1, PHASE2
· not yet recruiting
Other recruiting trials for Rectal Cancer
Currently open trials in the same condition.
NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer
· Phase 3
· recruiting
NCT07537998 — Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a
· Phase 2, PHASE3
· recruiting
NCT07369531 — The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-pres
· NA
· recruiting
NCT07505472 — Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Wit
· Phase 2, PHASE3
· recruiting
Other Asan Medical Center trials
Trials by the same sponsor.
NCT07530393 — Blood Viscosity and Outcomes After Elective Craniotomy
· not yet recruiting
NCT07010497 — A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Be
· Phase 2
· recruiting
NCT07382505 — Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cerv
· not yet recruiting
NCT07489092 — Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge
· NA
· recruiting
NCT07431762 — Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprpsthetic Hear
· Phase 4
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Asan Medical Center
Last refreshed: 4 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01781403.